Pilot/Pivotal Study of DBS+Rehab After Stroke

Purpose

The RESTORE Stroke Study will evaluate the safety and effectiveness of DBS+Rehab for treating arm weakness and reduced function after a stroke.

Conditions

  • Stroke
  • Upper Extremity Paresis

Eligibility

Eligible Ages
Over 21 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Ischemic stroke, with an initial incident occurring between 12 months to 6 years before implant, resulting in residual upper extremity hemiparesis.

Exclusion Criteria

  • Previous or subsequent cerebrovascular events resulting in residual upper extremity impairment - Brain lesions with significant involvement of the brainstem, cerebellum, or thalamus

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Double-blinded, randomized, parallel study with partial crossover.
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Participants, Care Providers (Therapists), Investigators, and Outcome Assessors do not know to which group the participants are randomized.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
DBS+Rehab 		Active-DBS combined with motor rehabilitation
  • Device: Deep Brain Stimulation
    Deep Brain Stimulation (DBS) of the dentate nucleus area of the cerebellum plus motor rehabilitation to improve upper-extremity function.
Active Comparator
Rehab 		Control-DBS combined with motor rehabilitation
  • Device: Deep Brain Stimulation
    Deep Brain Stimulation (DBS) of the dentate nucleus area of the cerebellum plus motor rehabilitation to improve upper-extremity function.
  • Other: Rehabilitation
    Motor rehabilitation to improve upper-extremity function.

Recruiting Locations

Massachusetts General Hospital
Boston, Massachusetts 02114
Contact:
Erin Donahue, PhD
617-643-3732
ekdonahue@mgh.harvard.edu

More Details

Status
Recruiting
Sponsor
Enspire DBS Therapy, Inc.

Study Contact

Detailed Description

The RESTORE Stroke Study combines two phases of study under one protocol (pilot/pivotal). The first phase has a sample size of 40 subjects. The second phase has an estimated sample size of 162 subjects which may be adjusted based on analysis of the first phase. Each subject will be implanted with the DBS system, undergo DBS program optimization, and be randomized to test treatment (Tt) or active-control treatment (Ct). After randomization, all subjects will participate in a five-month outpatient rehabilitation therapy program. After five months of blinded randomized testing, subjects assigned to active-control treatment (Ct) will cross over to receive test treatment (Tt) and participate in a second five-month therapy program.